Sterility Assurance Manager — Global Compliance & CCS Lead

Lonza; Stein (AR); Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Stein, Switzerland, is seeking a Sterility Assurance lead to drive compliance with EU GMP Annex 1 and strengthen contamination control across a growing site.

You will champion aseptic manufacturing excellence, support product introductions, and collaborate with global teams to safeguard patient safety and product quality. On-site role with up to 20% remote work, fostering real-time collaboration and technical precision.

Qualifikationen

• Proven expertise in sterility assurance and compliance with EU GMP Annex 1 requirements.
• Experience implementing and maintaining Annex 1 in sterile manufacturing environments.
• Strong knowledge of CCS and contamination control programs.
• Hands-on experience with aseptic processing and media fills is preferred.
• Excellent communication and ability to influence at audits and inspections.

Aufgaben

• Lead the site's sterility assurance strategy with regulatory compliance focus.
• Oversee Contamination Control Strategy, including environmental monitoring and cleaning.
• Support facility design, qualification, validation, tech transfers, and new product introductions.
• Drive risk assessments, trend analyses, and training to elevate sterility performance.
• Represent QA during inspections and regulatory interactions; ensure readiness.

Kenntnisse

Sterility assurance

EU GMP Annex 1

Contamination control

Aseptic processing

Root-cause analysis

Cross-functional collaboration

English proficiency

German language

Jobbeschreibung

Lonza in Stein, Switzerland, is seeking a Sterility Assurance lead to drive compliance with EU GMP Annex 1 and strengthen contamination control across a growing site.

You will champion aseptic manufacturing excellence, support product introductions, and collaborate with global teams to safeguard patient safety and product quality. On-site role with up to 20% remote work, fostering real-time collaboration and technical precision.